{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Marlborough",
      "address_1": "300 Boston Scientific Way",
      "reason_for_recall": "Supplier had changed its resin sub-suppliers three (3) times without notifying BSC.  These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation.  Not approved in customer document.",
      "address_2": "",
      "product_quantity": "1,282 (all three types in Japan)",
      "code_info": "IntellaNav Open-Irrigated Ablation Catheter  Material Number: M004R96200  Batch: 22208397 Expiration Date: 6/4/2021  Batch: 22389516 Expiration Date: 7/16/2021  Batch: 22525798 Expiration Date: 2/14/2020",
      "center_classification_date": "20190108",
      "distribution_pattern": "Japan",
      "state": "MA",
      "product_description": "IntellaNav MiFi Open-Irrigated Ablation Catheter    Product Usage:  Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for:   Cardiac electrophysiological mapping   Delivering diagnostic pacing stimuli   RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older   Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system",
      "report_date": "20190116",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Boston Scientific Corporation",
      "recall_number": "Z-0701-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81747",
      "more_code_info": "",
      "recall_initiation_date": "20181128",
      "postal_code": "01752-1291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}